Roll Call and Govexec bring us up to date on the lame-duck session’s agenda.
The Washington Post tells us about the Administration’s plans to include $10 billion in Covid funding in the omnibus appropriations bill that Congress must pass or extend by December 16.
The Wall Street Journal reports “Republicans have won 217 House seats to the Democrats’ 205, according to the Associated Press tally. A party needs 218 for a majority in the chamber, and Republicans were on track for a very narrow margin after they won seats Monday in Arizona, California and New York. ” This development increases the likelihood that Congress will pass an omnibus appropriations bill before year-end.
The Congressional Budget Office posted a presentation on its recommended policy approaches to reduce commercial health Insurer payments for hospitals’ and physicians’ services. The presentation is worth a gander because the American Hospital Association, among others, is not pleased with the CBO’s recommendations.
The American Medical Association shares developments from its interim meeting which concludes tomorrow.
Fierce Healthcare offers a news feed from the HLTH 2022 conference.
From the Affordable Care Act front, the Internal Revenue Service announced the PCORI support fee that health plans must pay for policy years and plan years that end on or after October 1, 2022, and before October 1, 2023. In short, the dollar amount that calendar year plans such as the FEHB plan must pay next July 31 is $3.00 times the average number of covered lives.
From the Alzheimer’s Disease and dementia front, Medscape reports
“Dementia prevalence is dropping in the United States, new research shows.”
“Of the more than 6 million Alzheimer’s patients in the U.S. age 65 or older, nearly two-thirds are women. A new study may help explain the gender gap — and offer clues to new treatments for helping patients of both sexes fight back.” The FEHBlog has been taking a continuing legal education course on eldercare, and the practicing lawyers teaching the court remarked that 95% of the clients for whom Medicaid nursing home coverage is sought are husbands.
“Among older adults who use the US Supplemental Nutrition Assistance Program (SNAP), rates of memory decline appear to be slower than among those who don’t use the program, new research shows.”
An experimental Alzheimer’s drug from Roche Holding AG failed to significantly slow cognitive decline in long-awaited trials, the latest in a long line of setbacks for a field that has seen little progress in decades.
The drug, called gantenerumab, slightly reduced cognitive decline in people with early Alzheimer’s compared with a placebo across two large and lengthy trials, but the difference wasn’t statistically significant, Roche said Monday. The trials, which lasted more than two years and involved nearly 2,000 participants, compared scores of cognition and function in areas such as memory, orientation and problem-solving. * * *
The news comes just weeks after clinical trial results from a drug developed jointly by Biogen Inc. and Eisai Co. infused fresh hope into a field that has been marked by failure. The Biogen and Eisai drug, called lecanemab, reduced cognitive and functional decline by 27% compared with a placebo. The companies say they plan to provide more detailed study results at an upcoming research conference.
Like lecanemab, Roche’s gantenerumab targets accumulations of beta-amyloid, a protein that is found in the brains of people with Alzheimer’s and is thought to be linked to the disease. Several earlier beta-amyloid-targeting drugs had failed in clinical trials, although each drug acts slightly differently.
Roche Chief Executive Severin Schwan said last month that the Biogen and Eisai results were encouraging, but cautioned that they didn’t shed any light on the likely success of gantenerumab. Roche said Monday that the level of beta-amyloid removal by gantenerumab was lower than expected in the trials.
In other news —
Per Fierce Healthcare, Aetna announced a new advanced price care program in cooperation with Crossover Health. The program will launch next January 1 in the Seattle Washington region. “The new hybrid care model is integrated into a health plan and aims to tackle the rising access issues and costs of healthcare with a fixed fee, value-based payment model, executives said.”
Milliman offers its thoughts on mental health challenges facing employers.
As it gets colder and more people move their activities indoors, the recent decline in Covid-19 cases across the United States has started to level off. Coronavirus-related hospitalizations are ticking up in a number of states, including Arizona, Indiana, Illinois, Nevada, Nebraska, Oklahoma, South Dakota and Wisconsin. And there have been a variety of unnerving headlines about the immune evasion and increased transmissibility of the next round of coronavirus subvariants.
At least half a dozen versions of the virus are competing to become the next dominant strain in the United States, but they are part of the same family tree. “They are all offspring of Omicron,” said Dr. Albert Ko, a physician and epidemiologist at the Yale School of Public Health. Though each subvariant has slightly different mutations, none of them seem to be creating significant waves just yet, the way the Delta and Omicron variants did when they first appeared, Dr. Ko said.
From the Omicron and siblings front, the Center for Disease Control’s weekly interpretation of its Covid statistics tells us
Cases
As of November 2, 2022, the current 7-day average of weekly new cases (39,016) increased 4.7% compared with the previous 7-day average (37,261). A total of 97,604,763 COVID-19 cases have been reported in the United States as of November 2, 2022.
Variant Proportions
CDC Nowcast projections for the week ending November 5, 2022, estimate that the combined national proportion of lineages designated as Omicron will continue to be 100%.
Two BA.5 offshoots, BQ.1 and BQ.1.1, are gaining ground in the U.S., now accounting for an estimated 35% of cases this past week, CDC data show. Researchers and health officials have flagged both BQ variants and another variant called XBB as strains to watch, in part because they might heighten the risk for reinfection or evade certain treatments.
Hospitalizations
The current 7-day daily average for October 26–November 1, 2022, was 3,272. This is a 1.0% decrease from the prior 7-day average (3,306) from October 19–25, 2022.
Deaths
The current 7-day average of new deaths (358) decreased 3.0% compared with the previous 7-day average (369). As of November 2, 2022, a total of 1,068,667 COVID-19 deaths have been reported in the United States.
Vaccinations
As of November 2, 2022, 640.9 million vaccine doses have been administered in the United States. Overall, about 266.4 million people, or 80.2% of the total U.S. population, have received at least one dose of vaccine. About 227.4 million people, or 68.5% of the total U.S. population, have completed a primary series.
Of those who have completed a primary series, about 112.5 million people have received a booster dose, and more than 26.38 million people have received an updated (bivalent) booster dose. But 49.1% of the total booster-eligible population has not yet received a booster dose.
New data from Pfizer and BioNTech on their bivalent Covid-19 vaccine suggests the updated product may be more protective against more recent Omicron subvariants than the original version of the vaccine, the companies said in a statement released Friday.
The companies said the levels of neutralizing antibodies that target the BA.4 and BA.5 subvariants of the SARS-CoV-2 virus were four-fold higher in people aged 55 and older who received the bivalent booster than in similarly aged people who received a monovalent booster.
The CDC’s Fluview tells us that for the week ended last Saturday
Early increases in seasonal influenza activity continue nationwide. The southeastern and south-central areas of the country are reporting the highest levels of activity followed by the Mid-Atlantic and the south-central West Coast regions.
CDC estimates that, so far this season, there have been at least 1,600,000 illnesses, 13,000 hospitalizations, and 730 deaths from flu.
The cumulative hospitalization rate in the FluSurv-NET system is higher than the rate observed in week 43 during every previous season since 2010-2011.An annual flu vaccine is the best way to protect against flu.
Vaccination helps prevent infection and can also prevent serious outcomes in people who get vaccinated but still get sick with flu.
CDC recommends that everyone ages 6 months and older get a flu vaccine annually.
There are also prescription flu antiviral drugs that can be used to treat flu illness; those need to be started as early as possible.
Forbes informs us about the availability of an RSV immune agent
While clinical trials are currently underway to provide RSV vaccines to pregnant women in order to protect their soon-to-be newborns from RSV infections, pediatric specialists have been administering an RSV “vaccine” for years. This vaccine, called palivizumab (Synagis) isn’t actually a vaccine. It is a preventative monoclonal antibody injection which has been available to high-risk infants since 1998.
This therapy is administered as an injectable agent, thus was given the vernacular “vaccine” term, even though it is not a vaccine, nor does it act as one. It is an immune agent, providing antibody protection from severe RSV infections in vulnerable infants. It is given as an injection every month for five consecutive months. It was shown to reduce hospitalization by an average of 50% in two large placebo-controlled double-blind studies which included a total of nearly 3,000 high-risk babies.
[T]he American Academy of Pediatrics has presented updated guidelines for use of Synagis during any time where a particular region is experiencing a surge of RSV cases:
“With the shift in seasonality noted in 2021 and the current regional variability in interseason RSV cases, the AAP continues to support the use of palivizumab in eligible infants in any region experiencing rates of RSV activity at any time in 2022 similar to a typical fall-winter season. The AAP recommends initiating the standard administration of palivizumab, which consists of 5 consecutive monthly doses.”
From the healthcare cost front, Employee Benefits News reports
The Business Group on Health named cancer as the top driver of employer healthcare costs, a spot previously held by musculoskeletal conditions. In fact, 13% of employers surveyed say they have seen more late-stage cancers impacting their workforce, and 44% predict they will see an increase in cancer diagnoses in the future.
Again, Kelsay points out that delays in screenings, such as mammograms and prostate exams, left many Americans to unknowingly live with cancer. An estimated 64% of Americans deferred cancer screenings in 2021, according to the American Society of Clinical Oncology. And as a condition that can take months or years to treat, cancer is incredibly costly. The National Cancer Institute estimates the average cost of medical care and drugs is approximately $42,000 in the year following a cancer diagnosis.
“A lot of cancer treatments require immunotherapies, which are very expensive pharmaceuticals, as well as hospital stays and surgeries,” says Kelsay. “Cancer is just a terribly expensive condition to have.”
EBRI offers a detailed report on out of pocket spending in employer sponsored plans.
From the U.S. healthcare business front, Fierce Healthcare relates
Kaiser Permanente posted a $1.6 billion profit for the third quarter, which is down by nearly half from the $3 billion it generated in the previous quarter.
The 39-hospital system and health plan’s earnings, reported Friday, were affected by a major surge of COVID-19 that caused expenses to increase. Kaiser Permanente’s hospital system and health plan reported total operating revenue of $23.2 billion and expenses of $23 billion.
From the virtual care front, mHelath Intelligence reports
Recent survey results released by Elevance Health found that most Americans who participated in virtual primary care said their experience was satisfactory and that the service effectively enabled them to manage their health.
Formerly known as Anthem Inc., Elevance Health is a health insurer. Through the survey, Elevance aimed to gather data on virtual primary care, its outcomes, and what patients think. The payer commissioned the Harris Poll to conduct an online survey of more than 5,000 US adults aged 18 and over.
Researchers found that 79 percent of study participants believed virtual primary care allowed them to take charge of their health, and 94 percent were satisfied with their experience. * * *
These survey findings come on the heels of a report released at the end of October, which found that telehealth was highly used among those engaging in primary care and mental health services. It also showed that patient satisfaction with telehealth was high.
From the miscellany department, The New York Times offers advice to insomniacs.
A good night’s sleep can make us more empathetic, more creative, better parents and better partners, according to Aric Prather, a psychologist at the University of California, San Francisco who treats insomnia and is the author of the new book “The Sleep Prescription.” Sleep can help us manage stress; it can make us competent and capable and better able to take on the day. But Dr. Prather says we too often view sleep as an afterthought — until we find ourselves frozen in the middle of the night, our thoughts racing, fumbling for rest or relief.
November is awareness month for diabetes and C. Diff. Looking back at October, Medscape informs us
Maintaining a healthy body weight, being physically active, and following a healthy dietary pattern can help women live longer after breast cancer diagnosis, according to a major new analysis of the latest research.
From the Federal Employee Benefits Open Season front, the Federal Times offers its consumer guide.
The Centers for Medicare & Medicaid Services [CMS] late today posted a final rule on its website that will increase Medicare hospital outpatient prospective payment system rates by a net 3.8% in calendar year 2023 compared to 2022. This update is based on a market basket percentage increase of 4.1%, reduced by 0.3 percentage points for productivity. [AHA calls the increase insufficient.] * * *
CMS finalized the payment policy for CY 2023 of average sales price (ASP) +6% for drugs and biologicals acquired through the 340B Program as a result of the unanimous Supreme Court decision in American Hospital Association v. Becerra.
CMS also finalized proposals to establish the Rural Emergency Hospital (REH) model, a new provider type for eligible critical access hospitals and small rural hospitals beginning in Jan. 1, 2023. The rule finalized proposals related to model payment, covered services, conditions of participation, and quality measurements.
[and]
The Centers for Medicare & Medicaid Services today released on its website its calendar year 2023 final rule for the physician fee schedule. The rule will cut the conversion factor to $33.06 in CY 2023 from $34.61 in CY 2022, which reflects the expiration of the temporary 3% statutory payment increase; a 0.00% conversion factor update; and a budget-neutrality adjustment.
CMS evaluated two and a half years of readmission cases for Medicare patients through the Hospital Readmissions Reduction Program and penalized 2,273 hospitals that had a greater-than-expected rate of return, according to a Nov. 1 report from Kaiser Health News.
The average payment reduction was 0.43 percent, the lowest rate reduction since 2014. Reductions will be applied to each Medicare payment to the affected hospitals from Oct. 1 through next September. It is expected to cost the hospitals $320 million over the 12-month period.
The report notes that the COVID-19 pandemic caused turmoil in hospitals and that CMS decided to exclude the first half of 2020 from the report due to the chaos. CMS also excluded Medicare patients who were readmitted with pneumonia across all three years because of the difficulty distinguishing them from COVID patients.
From the Affordable Care Act preventive services front, Healio tells us
The U.S. Preventive Services Task Force has released two final recommendations on the use of hormone therapy for the primary prevention of chronic conditions in postmenopausal people.
The recommendations advocate against the use of menopausal hormone therapy (MHT) through a combination of estrogen and progestin in postmenopausal people, and MHT through estrogen alone in postmenopausal people who have had a hysterectomy.
Both are D-grade recommendations and are consistent with the USPSTF’s previous recommendations on the treatment made back in 2017.
James Stevermer, MD, MSPH, a task force member, also noted in the press release that the recommendations are only for those who are considering hormone therapy to prevent chronic conditions following menopause.
“Those who wish to manage symptoms of menopause with hormone therapy are encouraged to talk with their health care professional,” he said.
From the prescription drug and vaccine development front —
Pfizer’s maternal vaccine against the respiratory syncytial virus [RSV] reduced the rate of severe illness in newborns by 81.8%, the company said Tuesday, meeting the goal of a pivotal study.
The company said that it plans to file the data on the vaccine with regulators by the end of the year and that it expects an eight-month review.
RSV is a common cause of illness and infection in young infants. By giving the vaccine during pregnancy, researchers hope antibodies generated by mothers would be transferred to infants. Currently, the pertussis vaccine and the influenza vaccine are given during pregnancy for this reason.
Vertex Pharmaceuticals, a Boston-based biotech company, * * * is testing a non-opioid drug for acute pain. Vertex’s drug, VX-548, aims to block the Nav1.8 sodium channel, which acts like a gate allowing pain signals to travel from the nerves to the brain.
VX-548 met its goals in late-stage trials evaluating the drug in people who underwent a bunionectomy or an abdominoplasty, the formal name for a tummy tuck. Vertex will run the same studies with more patients before seeking regulatory approval. The company hasn’t disclosed when data will be available beyond saying the trials will be quick since patients receive the drug for only 48 hours. Vertex is also testing VX-548 in nerve pain and eventually wants to see if it works for chronic pain.
If VX-548 passes its next big tests, it could offer a new option for people recovering from surgery or other medical procedures. Of course, plenty of other pain drugs that looked promising early on in testing never reached the market.
Fortunately, scientists are investing time and money on a variety of alternatives for pain.
From the Rx coverage front, BioPharma Dive relates
Eli Lilly’s new diabetes medicine Mounjaro outpaced Wall Street sales forecasts during the third quarter, fueled by strong patient demand and widening insurer coverage.
U.S. sales of the drug totaled $97 million between July and September, Mounjaro’s first full quarter on the market since its May 13 approval by the Food and Drug Administration. Payments related to a collaboration agreement with Mitsubishi Tanabe Pharma in Japan pushed global revenue for the quarter to $187 million, well above the consensus analyst forecast of $82 million.
“We have seen unprecedented demand for Mounjaro’s Type 2 diabetes launch in the U.S.,” said Anat Ashkenazi, Lilly’s chief financial officer, on a Tuesday call with analysts.
Lilly is also conducting a study to support an FDA marketing application for Mounjaro to be prescribed for weight loss.
Notably, Mounjaro showed a potent effect in reducing trial participants’ weight, a benefit that was also observed in a large study specifically assessing it as an obesity treatment. While it’s currently only approved to treat Type 2 diabetes, its potential as a medicine for both chronic conditions has made it one of Lilly’s most important products.
Lilly is currently conducting a second study in obesity and plans to complete an approval application in that indication should results, expected in April next year, also prove positive.
In U.S. healthcare business news, MedTech Dive reports
Johnson & Johnson agreed to acquire Abiomed, a Danvers, Mass.-based maker of heart pumps, for $16.6 billion.
The deal will contribute to J&J’s cardiovascular portfolio, complementing its Biosense Webster electrophysiology business, BTIG Analyst Marie Thibault wrote in a research note on Tuesday.
The deal has already been approved by both companies’ boards of directors and is expected to close before the end of the first quarter of 2023.
Finally, check out the NIH Director’s blog discussing “How the Brain Differentiates the ‘Click,’ ‘Crack,’ or ‘Thud’ of Everyday Tasks.”
If you’ve been staying up late to watch the World Series, you probably spent those nine innings hoping for superstars Bryce Harper or José Altuve to square up a fastball and send it sailing out of the yard. Long-time baseball fans like me can distinguish immediately the loud crack of a home-run swing from the dull thud of a weak grounder.
Our brains have such a fascinating ability to discern “right” sounds from “wrong” ones in just an instant. This applies not only in baseball, but in the things that we do throughout the day, whether it’s hitting the right note on a musical instrument or pushing the car door just enough to click it shut without slamming.
Now, an NIH-funded team of neuroscientists has discovered what happens in the brain when one hears an expected or “right” sound versus a “wrong” one after completing a task. It turns out that the mammalian brain is remarkably good at predicting both when a sound should happen and what it ideally ought to sound like. Any notable mismatch between that expectation and the feedback, and the hearing center of the brain reacts.
From the Omicron and siblings front, the National Institutes of Health announced
As SARS-CoV-2 — the coronavirus that causes COVID-19 — continues to spread, its genetic material mutates, leading to viral variants. These changes happen most often in the virus’s spike protein, which allows the virus to attach to and invade cells.
Because most COVID-19 vaccines are targeted to the spike protein, antibodies resulting from vaccinations provide less immune protection against variants. This increases people’s risk of getting COVID-19 despite vaccination.
Researchers at the National Institute of Allergy and Infectious Diseases (NIAID) are exploring a different idea for vaccines. Instead of focusing on the SARS-CoV-2 spike protein, they are studying the virus’s nucleocapsid (N) protein, which rarely mutates.1 The N protein could be the key to creating a future universal vaccine to fight emerging variants.
Fingers crossed.
In other public health news, the American Hospital Association tells us
Overall cancer death rates continued to decline between 2015 and 2019 for men, women and children and all major racial and ethnic groups, according to the latest Annual Report to the Nation on the Status of Cancer. The overall death rate fell an average 2.3% per year in men and 1.9% per year in women, led by declining rates for lung cancer and melanoma. Death rates increased in men for cancers of the pancreas, brain, bones and joints and in women for cancers of the pancreas and uterus. New cancer cases remained stable for men and children between 2014 and 2018, but increased for women, adolescents and young adults. This year’s report also highlights trends in pancreatic cancer, as well as racial and ethnic disparities in incidence and death rates.
MedCity News points out three reasons why Americans are underutilizing primary care.
From the Federal Employee Benefits Open Season front, OPM informed agency benefit officers
Please see the attached document listing the 84 FEHB plan choices where the enrollee share of premiums for the Self Plus One enrollment type is higher than for the Self and Family enrollment type for the 2023 plan year.
Please share this information with your employees and inform them that enrollees who wish to cover one eligible family member may elect either the Self and Family or Self Plus One enrollment type.
Enrollees should carefully check the 2023 rates of their current plan and any other plan choices they are considering for 2023. For enrollees wishing to change, they must do so during Open Season, which is held from November 14th through December 12th.
In all of these cases, the self and family premium exceeds the self plus one premium. Nevertheless, these anomalies occur because FEHB family sizes are small and the self plus one government contribution is lower than the self plus family government.
A FedWeek expert identifies eight mistakes to avoid when shopping for a health plan during the Open Season.
The Kaiser Family Foundation released its 2022 Employer Health Benefits Survey.
In 2022, the average annual premiums for employer-sponsored health insurance are $7,911 for single coverage and $22,463 for family coverage. These amounts are each similar to the average premiums in 2021. In contrast to the lack of premium growth in 2022, workers’ wages increased 6.7% and inflation increased 8%.2 This difference may be due to the fact that many of the premiums for 2022 were finalized in the fall of 2021, before the extent of rising prices became clear. As inflation continues to grow at relatively high levels, we could potentially observe a higher increase in average premiums for 2023 than we have seen in recent years.
In other federal employment news,
FedWeek offers federal and postal employees advice on getting a head start on planning for retirement.
More federal employees are working onsite and more often this year than last, continuing a downward trend since the mid-2020 peak in offsite work caused by the pandemic, the Federal Employee Viewpoint Survey showed.
Thirty-six percent said they are present at their worksite all of the time, up from 29 percent in 2021 and 17 percent in 2020, while 18 percent said they had not been present onsite this year, down from 22 and 30 percent. The percentage who said they are onsite less than a quarter of the time fell over the three years from 24 to 20 and now 15.
While the share of full-time telework is down, many of those who are continuing to telework do so a substantial portion of their time, however. Those reporting that they telework three or four days a week now stands at 25 percent, up from 11-12 percent in the prior years, while those doing it one or two days a week stands at 17 percent, up from 8 and 10 percent.
and shares statistics on federal employee use of the new paid parental leave benefit as reported in the Federal Employees Viewpoint Survey — “Four percent of employees took at least some of that time over the last year.”
From the Affordable Care Act front, the Kaiser Family Foundation released its annually updated fact sheet on Preventive Services Covered by Private Health Plans under the ACA. “This fact sheet summarizes the federal requirements for coverage for preventive services in private plans, major updates to the requirement, and recent policy activities on this front.”
From the telehealth front —
Beckers Hospital Review offers an interview on the topic of “Telesitting, remote maternity care: Where telehealth is going next at Kaiser Permanente.”
Fierce Healthcare informs us “COVID-era emergency department patients who had follow-up appointments via telehealth more often returned to the ED or were hospitalized than those who followed up with doctors in person, according to a new retrospective study [published in JAMA Network Open]. * * * The researchers noted their investigation had several limitations, such as no data on certain “complex” social determinants of health like unemployment and whether patients received a follow-up outside of the health system. The findings “need to be considered in the context of a substantial body of science demonstrating the benefits of telemedicine,” such as those that found lower rates of rehospitalization in certain chronic condition populations tied to telehealth use.”
Healthcare Dive reports “Teladoc reported better than expected revenue in the third quarter, on the back of its mental health business, BetterHelp, and issued moderate fourth-quarter guidance, leading some industry watchers to say the telehealth vendor is setting itself up for achievable growth after uncertainty contributed to stock losses this year.”
In other U.S. healthcare business news
Politico brings us up to date on the low participation rate in the new federal designation of rural emergency hospitals. It’s back to the drawing board.
Beckers Payer Issues reports that CareFirst and Johns Hopkins Medicine “have signed a multiyear contract following a dispute over reimbursement rates that would have left hundreds of thousands of people out of network.” Cheers to that.
MedTech Dive informs us, “Labcorp lowers 2022 forecasts after Q3 profit falls on labor costs, declining COVID-19 revenue.”
Employers should know that the Equal Employment Opportunity slide has updated its workplace notice. HR Dive warns us, “Hang new EEO poster ‘as soon as possible,’ EEOC advises. An EEOC spokesperson also told HR Dive how employers with remote and hybrid employees should handle the poster.”
From the Rx coverage front
Reuters relates that “The U.S. Food and Drug Administration has delayed a meeting of its advisory panel to discuss Perrigo Co Plc’s (PRGO.N) over-the-counter (OTC) contraceptive, the drugmaker said on Wednesday. The meeting, scheduled for Nov. 18, was delayed to review additional information, and no new date has yet been set, in a setback for what was expected to be the first approved daily OTC birth control pill in the United States.”
Amid sporadic shortages of a drug that is essential in preparing patients for lifesaving, cancer-fighting treatments, one manufacturer has returned to the market — but is selling its medicine for 10 to 20 times the prices offered by the only other companies with available supplies.
Over the past week, Areva Pharmaceuticals began marketing vials of fludarabine at a wholesale price of $2,736, a much steeper cost than the $272 charged for the same dosage by Fresenius Kabi and the $109 price tag from Teva Pharmaceuticals, according to data from IBM Micromedex, which gathers pricing data that is reported by manufacturers.
The move comes as hospitals around the U.S. grapple with persistent shortages of fludarabine, an older chemotherapy that is used during the run-up to bone marrow transplants in patients with a form of leukemia. More recently, the drug has also become a crucial tool in readying patients to undergo CAR-T cell therapy, a customized approach to fighting some cancers that involves re-engineering patient cells.
That’s a big bowl of wrong.
Let’s conclude with this wonderful piece of Govexec miscellany explaining the genesis of federal government shutdowns in the late 1970s.
My Federal Retires explains Open Season options available to those with Medicare coverage.
Govexec promotes healthcare flexible savings accounts, which are only available to federal and Postal employees. The FEHBlog was surprised to learn that “less than 20% of active feds have an FSA.” The article explains the mechanics of the FSA, among other things.
In other federal employee benefits news, Reg Jones, writing in the Federal Times, tells us how to calculate federal disability retirement benefits and answers a question about survivor annuitant coverage.
In other OPM news, Govexec tells us how the OPM Director is celebrating Work and Family Month.
From the Omicron and siblings front, Beckers Hospital Review informs us that “Omicron subvariants BQ.1 and BQ.1.1 — dubbed “escape variants” for their immune evasiveness — are steadily gaining prevalence in the U.S. and now account for more than 16 percent of all COVID-19 cases confirmed nationwide, CDC data shows.”
Data analysis from the Los Angeles-based Smidt Heart Institute at Cedars-Sinai found heart attack deaths rose significantly with COVID-19 surges, including omicron surges.
Heart attack deaths were on the decline before the pandemic. However, during COVID-19 surges, deaths increased — especially among individuals ages 25-44, according to an Oct. 24 release shared with Becker’s.
In other public health news
The Wall Street Journal and the New York Times warn us about a potential “tripledemic” of Omicron, the flu and RSV occurring this winter.
A new national study has suggested that chemical hair straighteners could pose a small risk for uterine cancer. Rates of the disease are still relatively low, said Dr. Alexandra White, head of the environment and cancer epidemiology group of the National Institute of Environmental Health Sciences and the lead author on the study. The research also did not definitively show that hair straighteners cause cancer. But the findings are cause for concern, she said.
Rates of uterine cancer have been increasing in the United States, particularly for Black and Hispanic women. The number of cases diagnosed each year rose to 65,950 this year, compared to 39,000 15 years ago. Black women are also more likely to have more aggressive cases of the cancer, Dr. White said, and the study showed they were disproportionately more likely to use hair straighteners.
If you have used chemical hair straighteners, you do not need to seek out medical attention or consult your doctor unless you have symptoms for uterine cancer, said Dr. Otis Brawley, an oncologist at Johns Hopkins University. But women should regularly see a gynecologist, and be aware of the risk factors and early signs of the disease. [The article also explains uterine cancer risk factors and symptoms.]
The Biden administration is preparing a comprehensive initiative to fight hepatitis C that would streamline testing and treatment and secure an agreement with drugmakers to bring down the cost of treatment of the disease, which has spiked during the pandemic.
Francis Collins, special project adviser to President Joe Biden and former longtime director of the National Institutes of Health, said Monday the administration hopes to secure some funding this year for the yet to be formally unveiled initiative.
He said he has briefed Biden on the plan, and the Office of Management and Budget is “enthusiastic about figuring out how to fit this into the budgetary requests.”
Long-term use of electronic cigarettes, or vaping products, can significantly impair the function of the body’s blood vessels, increasing the risk for cardiovascular disease. Additionally, the use of both e-cigarettes and regular cigarettes may cause an even greater risk than the use of either of these products alone. These findings come from two new studies supported by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH).
The Food and Drug Administration on Tuesday approved a first-of-its-kind treatment for multiple myeloma from Johnson & Johnson, but put restrictions on its use due to the drug’s potentially dangerous side effects.
Healthcare providers offering the drug, which will be sold as Tecvayli, will need to follow guidelines set up in a Risk Evaluation and Mitigation Strategy, or REMS. Prescribers and pharmacies must be certified in the Tecvayli REMS program, which will focus on monitoring and counseling for patients.
The FDA has required REMS for dozens of medicines since the program was authorized by Congress in 2007. The list includes Bristol Myers Squibb’s cell therapy Abecma, which won approval for multiple myeloma last year.
AstraZeneca’s long-troubled cancer immunotherapy tremelimumab has finally secured its first FDA approval, but the regulatory blessing comes in what could be an increasingly competitive tumor type.
To be sold under the brand name Imjudo, tremelimumab has won an FDA go-ahead in combination with AstraZeneca’s PD-L1 inhibitor Imfinzi for treating unresectable hepatocellular carcinoma, the most common type of liver cancer.
The FDA nod officially puts an end to the streak of clinical trial failures that tremelimumab endured over recent years in multiple cancer types, including non-small cell lung cancer, head and neck cancer and bladder cancer. But while the CTLA-4 inhibitor has now crossed the regulatory finish line, a commercial fight lies ahead.
From the Medicare front – –
STAT News discusses a new CMS policy aimed at controlling dialysis prices.
Fierce Healthcare tells us “Starting next year, insurers will not be able to air any television ads for Medicare Advantage (MA) plans before getting approval from federal regulators.” Tough break for Joe Namath.
From the ACA marketplace front —
The Department of Health and Human Services discusses its plans for the upcoming Open enrollment period.
Benefits Pro discusses the popularity of alternative health reimbursement accounts which allow employers to offer marketplace coverage to their employees.
Speaking of account-based health plans, the Plan Sponsors Council of America released its 2022 benchmarking survey of health savings accounts.
From the U.S. healthcare business front —
Health Data Management assesses whether Amazon and Walmart can build effective value based care models.
CVS Health released “The Rx Report: A New Day in Retail Pharmacy, highlighting the results of a CVS Health/Morning Consult survey, which identified strong consumer preference and demand for an expanded role of pharmacists.”
The Department of Health and Human Services will launch a national advertising campaign and tour to encourage families to get the updated Pfizer or Moderna COVID-19 vaccine booster to protect themselves against the omicron variants before winter and the holiday season, the White House announced today. As part of the tour, HHS will host pop-up vaccination events, and encourage others to share information on COVID-19 vaccines and host vaccination events.
Whereas alpha, beta, gamma and the other named variants sprouted new branches on the SARS-CoV-2 family tree, those limbs were dwarfed by the omicron bough, which is now studded with a plethora of subvariant stems.
“The children of omicron — so the many direct children and cousins within the diverse omicron family — those have displaced each other” as the dominant strains driving the pandemic, says Emma Hodcroft, a molecular epidemiologist at the University of Bern. “But that same family has been dominating” by outcompeting other strains.
The article delves into the future as well.
From the Rx coverage front —
Fierce Healthcare tells us that health insurer Centene announced its third-quarter results and a new PBM contract with Express Scripts.
Florida Blue Cross announced a mail-order pharmacy agreement with Amazon.
From the telehealth front —
The Federal Times discusses FEHB telehealth coverage available in 2023.
As federal employees prepare to make their selections for next year’s health insurance benefits, some may wonder whether telehealth services, made especially popular and necessary by the COVID-19 pandemic, will stick around.
For the most part, beneficiaries under the Federal Employee Health Benefits program will not see a major drop-off of telehealth options for 2023, said the White House’s Office of Personnel Management’s Edward DeHarde, who leads federal employee insurance operations, in an interview.
While the Federal Times article is focused on the hub and spoke telehealth services, STAT News considers the growing practice of pharmaceutical manufacturers making their drugs available to consumers through a third-party telehealth service.
From the tidbits department
The Wall Street Journal discusses the impact of health insurance spending on the consumer price index. In short, “The subindex of the consumer-price index is about to turn from a driver of inflation into a deflationary drag.”
The U.S. Public Health Service Task Force released for public comment a draft I (or inconclusive_ recommendation: “The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of visual skin examination by a clinician to screen for skin cancer in [asymptomatic] adolescents and adults.” The comment deadline is November 21, 2022.
CNN reports “One in 10 Americans over 65 had dementia, while 22% experienced mild cognitive impairment, the earliest stage of the slow slide into senility, according to a new study conducted between 2016 and 2017.” The study — the first in 20 years — breaks down its results by demographic categories.
My Federal Retirement offers its take on Medicare income adjusted premiums, known as IRMAA.
Employees and retirees are to be reminded that the IRMAA determination is usually based on Medicare Part B beneficiary’s federal income tax returns from two years earlier [e.g. 2021 governs 2023]. If a beneficiary’s income has dropped in the following year, then the beneficiary can appeal the IRMAA decision using Social Security Form SSA-44 (Medicare Income-Related Monthly Adjustment Amount -Life-Changing Event), providing proof that the beneficiary has experienced a “life-changing” event such as the death of a spouse or a divorce resulting in a significant decrease in income in the following year.
This is Red Ribbon Week, “an ideal way for people and communities to unite and take a visible stand against drugs.”
Speaking of illegal drugs, the Wall Street Journal tells the stories of three “high achieving” New York City dwellers who died on one day in March 2021 due to fentanyl-laced cocaine delivered by a single dealer.
New York City authorities have been warning of the risks of unknowingly taking fentanyl in cocaine and of its increased presence in cocaine seized by police. Health officials put up posters and sent drink coasters to clubs warning cocaine users to start with a small dose and to have naloxone, an opioid reversal drug, on hand to counter an overdose. They are handing out fentanyl testing strips that can be used to test cocaine and other drugs for fentanyl’s presence.
Multiple people died within hours from tainted cocaine in Long Island, N.Y., and in Newport Beach, Calif., last year. Nine were killed in Washington, D.C., in January. Law-enforcement officials said dealers often use coffee grinders or other basic equipment to cut drugs and prepare them for sale, which can result in deadly batches.
From the FEHB front, Tammy Flanagan, writing in Govexec, advises federal and postal employees and annuitants on how to prepare for the upcoming Federal Employee Benefits Open Season. The FEHBlog’s advice is to stack your plan’s summary of benefits and coverage which is available on all FEHB plan websites against other plans in which you are interested. The summary of benefits and coverage, which is an Affordable Care Act requirement, is four double-sided pages including consumer-tested practical information.
From the Omicron and siblings’ front
STAT News reports “FDA’s vaccines chief [Peter Marks, MD] sees the possibility of more Covid boosters — sooner than he’d like.”
Pfizer is considering hiking the price of its COVID-19 vaccine by roughly four times what it currently charges as it prepares for sales in the U.S. to shift from government contracts to the private market.
The pharmaceutical company is targeting between $110 and $130 per adult vaccine dose after that transition, said Angela Lukin, Pfizer’s head of global primary care and U.S. president, on an analyst and investor call Thursday.
“We feel confident that this range will be seen as highly cost effective and definitely one that will help to enable and ensure appropriate access and reimbursement to the vaccine,” Lukin said on the call. Discussions with insurers are still in early stages, she added.
No doubt this charming development seeks to pressure Congress to add more federal Covid dollars in the lame-duck session following the November 8 Congressional election.
In other vaccine news, MedPage Today reports
The CDC’s vaccine advisors updated their recommendations to clarify when to administer the 20-valent conjugate pneumococcal vaccine (PCV20; Prevnar 20) in adults who previously received the 13-valent conjugate vaccine (PCV13; Prevnar 13).
Three doses of hepatitis B vaccine with a cytosine phosphoguanine adjuvant (HepB-CpG; Heplisav-B) notched a perfect mark when it came to seroprotection for people with HIV who had never before been vaccinated against the hepatitis B virus (HBV), early results of a phase III trial showed.
In prescription drug development news, Fierce Healthcare points out “three drugs are set for FDA determinations soon.” The article explains why Optum says payers should take notice.
Cases of monkeypox are continuing to decline in the U.S., but the disease is still disproportionately affecting people of color, a White House official said.
“In the U.S., about 27,635 cases were reported as of yesterday,” Demetre Daskalakis, MD, White House National Monkeypox Response deputy coordinator, said at an online briefing Thursday. “We continue to have a decrease over time — we’re about 85% down from where we were at the peak of the outbreak. So that’s a lot of hopeful news, that we continue to see monkeypox going under better and better control.”
From the mental healthcare front, the Department of Health and Human Services “through the Substance Abuse and Mental Health Services Administration (SAMHSA), announced more than $100 million this week in funding from the Bipartisan Safer Communities Act (BSCA) to states and territories for mental health emergency preparedness, crisis response, and the expansion of 988 Suicide & Crisis Lifeline services. BSCA, signed into law by President Biden earlier this year, provided unprecedented funding to address the nation’s mental health crisis and make our communities safer.”
From the maternal care front, Health Payer Intelligence informs us Blue Cross and Blue Shield of Michigan has “decided to go beyond traditional maternal healthcare benefits, such as prenatal and postpartum care coverage. They teamed up with a virtual care provider for women and family health, Maven, to offer a suite of solutions that integrated family care and maternal healthcare.”
In a letter to HHS Secretary Xavier Becerra and Management and Budget Office Director Shalanda Young, AHIP explained its vision for how demographic data can be improved and standardized across the healthcare system.
Five things to know about the association’s recommendations for improving demographic data:
1. Current challenges with demographic data include the lack of specificity for questions on race. AHIP highlights that current census and HHS standards do not include an option for people to identify as Arab, Middle Eastern or North African. Additionally, AHIP recommends options should be tailored to the local area, depending on the populations that live there.
2. Current demographic questions do not have an “I choose not to respond” option. AHIP advises that a lack of information about how demographic information is used can lead to a lack of trust from patients.
3. Current regulations that require multiple providers and payers to collect demographic information lead to inconsistent results and greater burden on patients, AHIP says.
4. To reduce burdens on providers and patients, AHIP wants demographic data to be electronic and able to be shared with other places in the healthcare system with patient consent.
5. AHIP wants a wide range of government agencies to adopt its recommendations for demographic data collection, which include questions on race, ethnicity, language preference, sexual orientation, gender, diability status, veteran status and spirtual beliefs.
STAT New discusses weaknesses in traditional Medicare catastrophic coverage. FEHBlog suggests that Congress stop permitting Medicare supplemental plans to impose pre-existing condition limitations unless circumscribed by state law.
The Society for Human Resources Management tells us
Employee 401(k) contributions for 2023 will top off at $22,500—a $2,000 increase from the $20,500 cap for 2022—the IRS announced on Oct. 21. Plan participants age 50 or older next year can contribute an additional $7,500, up $1,000 from 2022. * * *
he limit on total employer-plus-employee contributions to defined contribution plans will increase to $66,000 in 2023, up by $5,000 from $61,000 in 2022. “This limit usually increases by $1,000 at a time but now it’s jumping five steps in one year,” Sit said.
The IRS announced the 2023 adjustments for 401(k) and similar defined contribution plans, and for defined benefit pension plan, in Notice 2022-55.
The American Hospital Association reports “The AHA and American Medical Association Oct. 19 filed a friend-of-the-court brief in support of a Texas Medical Association lawsuit claiming the revised independent dispute resolution process for determining payment for out-of-network services under the No Surprises Act skews the arbitration results in commercial insurers’ favor in ways that violate the compromise Congress reached in the Act.”
Business Insurance tells us “The U.S. Department of Justice has asked for more details on CVS Health Corp.’s proposed $8 billion deal to buy Signify Health, in a possible indication that the transaction will face a longer deal review rather than a quick approval, Reuters reports. The deal, announced last month, was expected to face a tough antitrust review even though the two companies do not compete directly in any market, according to experts.”
Following up on last Thursday’s post, RSV is a type of common cold according to the CDC.
From the FEHB Open Season front, OPM issued today its annual open season benefits administration letter identifying FEHB and FEDVIP contract changes for 2023 A/K/A, the Significant Changes letter and appendix. OPM also released its Federal Benefits Fast Facts for the upcoming Open Season.
From the No Surprises Act front, Newfront, an insurance brokerage, issued an important reminder on the revised NSA consumer notice that health plans must post by January 1, 2023. Here are the current and future notices.
From the Covid vaccine mandate front, the Miller & Chevalier law firm tells us
On October 14, 2022, the Safer Federal Workforce Task Force released a roadmap for federal contractors of anticipated guidance on how federal agencies would be handling the implementation and enforcement of the federal contractor vaccine mandate and workplace safety requirements of Executive Order 14042, “Ensuring Adequate Safety Protocols for Federal Contractors.” The Task Force — created by President Biden to provide guidance to federal agencies on handling operational issues related to the COVID-19 pandemic — anticipates a “potential narrowing of the existing nationwide injunction on October 18, 2022.” As a result, the Task Force anticipates the release of three documents: (1) notice from the Office of Management and Budget (OMB) to federal agencies regarding compliance with injunctions and the inclusion of vaccine mandate clauses in future solicitations and contracts; (2) updates to Task Force guidance on safety protocols for covered contractor and subcontractor workplace locations, including a timeline for implementation; and (3) additional guidance from OMB on “timing and considerations for provision of written notice from agencies to contractors regarding enforcement of contract clauses” implementing vaccine and workplace safety mandates. Notably, until OMB issues the guidance above, agencies are directed not to take any steps to require compliance with the Task Force guidance or enforce any contract clauses implementing the requirements of Executive Order 14042.
This Task Force guidance stems from an August 26, 2022, U.S. Court of Appeals for the 11th Circuit opinion replacing the lower court’s nationwide injunction with an injunction applying to the plaintiffs. However, several other U.S. Courts of Appeals are hearing cases involving this mandate so we may be waiting a while for the OMB guidance.
Also, from the Omicron and siblings front, Beckers Hospital Review discusses the new Omicron variants BQ.1 and BQ1.1.
CDC estimates indicate a new omicron variant, BQ.1, and its descendent BQ.1.1 account for 11.4 percent of cases nationwide. The pair have been dubbed “escape variants” for their ability to escape immunity and are currently most prevalent in New York and New Jersey, where they account for nearly 20 percent of new infections. * * *
Experts are optimistic that the bivalent omicron boosters will offer protection against BQ.1 and BQ.1.1 since they’re descendants of BA.5. (Updated boosters are designed to target the original SARS-CoV-2 strain, BA.4 and BA.5.)
“The bad news is that there’s a new variant that’s emerging and that has qualities or characteristics that could evade some of the interventions we have. But, the somewhat encouraging news is that it’s a BA.5 sublineage, so there are almost certainly going to be some cross protection that you can boost up,” Dr. Fauci said.
From the monkeypox front, the American Hospital Association reports
The Centers for Disease Control and Prevention today reported the first U.S. monkeypox case in a health care worker since the outbreak began in May. The report describes how an emergency department nurse in Florida was exposed to the virus through a needlestick, and recommends approaches to preventing infections in health care workers. CDC also released a report describing five patients who acquired ocular monkeypox, a rare but sight-threatening condition, including four who were hospitalized. The report recommends health care providers advise monkeypox patients to practice hand hygiene and avoid touching their eyes, and consider urgent ophthalmologic evaluation and monkeypox-directed treatment for patients with ocular signs and symptoms.
The U.S. is seeing flu activity rise earlier than usual, with Southern states reporting the highest levels of activity, according to the CDC’s latest FluView report for the week ending Oct. 8.
Overall, activity remains low, “but increasing in most of the country,” the CDC said. HHS region 4 (Kentucky, Tennessee, Mississippi, Alabama, Georgia, South Carolina, North Carolina, Florida) and region 6 (New Mexico, Texas, Oklahoma, Arkansas, Louisiana) are reporting the highest levels of flu activity.
Furthermore, STAT News “talked on Friday with Lynnette Brammer, a flu epidemiologist and team lead for domestic surveillance in the CDC’s influenza division, to get a sense of what the agency is seeing.”
Thinking about this flu season and what you’re seeing so far, what’s your best guess for what’s ahead?
Our syndromic surveillance methods are much trickier to try and interpret now, with Covid in the picture. It just muddies the water, basically.
We’ll have to see if the flu and Covid circulate at the same time. Right now, it looks like Covid is still trending down in a lot of the country, but flu’s going up in a lot of the country.
If individuals start to feel crappy this winter, how will they know if it’s a cold? Flu? Covid?
I think testing is going to be really important given that, for flu and Covid, there are treatments that — particularly for high-risk people — can make a huge difference in how well they are able to get through their illness. So it’s going to be really important to test so physicians can know the appropriate treatment for their patients.
In related news, the Government Accountability Office released a report on routine vaccination rates in our country.
U.S. school children generally have higher rates of vaccination to protect them from preventable illness compared with adults.
We found gaps in adult rates for flu, shingles, tetanus, and pneumococcal (prevents pneumonia and more) vaccines. Among other things:
Adults were about 40% more likely to get the tetanus and pneumococcal vaccines than the shingles vaccine
Vaccination rates for Black or African American and Hispanic or Latino adults were about 13% below that of White adults for each vaccine
Health and Human Services is using social media and its website to raise public awareness on the importance of being vaccinated.
From the ACA reporting front, the Internal Revenue Service issued its Forms 1095-B and 1095-C for 2022. The Service also released an employee fringe benefits guide for federal, state, and local government employers.
From the Rx coverage front, BioPharma Dive predicts “five questions facing drugmakers as third-quarter earnings begin. Alzheimer’s study results, drug pricing law, bring new questions for many of the industry’s top companies.”
Forbes unpacks the colonoscopy study that the FEHBlog discussed in Monday’s post. The critical consideration is that “while colonoscopy may not be the gold standard it’s been made out to be, one or more colorectal cancer screening tools are essential to detect cancer and lower mortality rates.” Check it out.
Prof. Katie Keith writing in Health Affairs Forefront explores the final family glitch rule that the FEHBP mentioned in yesterday’s post. Two points suggest to the FEHBlog that the final rule will not materially impact the FEHB Program.
This situation—where employee-only coverage is affordable, but family coverage is not—is not uncommon. Most employers offer family coverage, but many do not subsidize it for family members which keeps the cost high for workers and their families.
That’s not the case in the FEHB Program. Moreover,
The final rule will not affect liability under the employer mandate, a fact confirmed by the IRS. Why not? The employer mandate requires certain large employers to offer coverage to employees and dependents. But penalties for violating the mandate are triggered only when an employee receives premium tax credits through the marketplace. The final rule extends premium tax credits to only the family members of workers who are not offered affordable job-based family coverage. It does not affect the eligibility of employees and thus does not implicate the employer mandate.
That’s an important consideration. Implementing the final rule is OPM’s responsibility as the FEHB Program’s regulator.
The White House on Tuesday said eligible Americans should get the updated COVID-19 boosters by Halloween to have maximum protection against the coronavirus by Thanksgiving and the holidays, as it warned of a “challenging” virus season ahead.
Dr. Ashish Jha, the White House COVID-19 coordinator, said the U.S. has the tools, both from vaccines and treatments, to largely eliminate serious illness and death from the virus, but stressed that’s only the case if people do their part. * * *
So far the Centers for Disease Control and Prevention says only about 11.5 million Americans have received the updated shots, which are meant to provide a boost of protection against both the original strain of COVID-19 and the BA.5 variant that is dominant around the world. Jha said studies suggest that if more Americans get the updated vaccines, “we could save hundreds of lives each day this winter.”
The American Hospital Association informs us
The Centers for Disease Control and Prevention today recommended Moderna’s bivalent COVID-19 vaccine booster for children aged 6-17 and Pfizer’s bivalent COVID-19 vaccine booster for children aged 5-11 after the Food and Drug Administration authorized them for these ages. CDC previously recommended the Pfizer bivalent booster for Americans 12 and older and the Moderna bivalent booster for adults. The boosters protect against the most recently circulating omicron variants as well as the original virus strain.
MedPage Today offers more information on this FDA decision and a modeling study of 1.2 million global Covid patients showing (1) “Long COVID — defined as one or more clusters of symptoms lasting three months or longer — occurred in about 6% of people with symptomatic SARS-CoV-2 infection” and (2) “at one year, 15% of long COVID patients had ongoing cognitive or respiratory problems or fatigue.”
In other public health news, NPR offers a transcript of a monkeypox discussion among NPR healthcare reports. The upshot is
Just a few months ago, it looked like the U.S. had lost its chance to get monkeypox under control. Cases were soaring, and vaccines were in short supply. But now the story has taken a turn and this time in a good direction. In fact, some disease experts are even raising the idea that the U.S. could nearly eliminate the virus.
Walmart is getting into clinical trials with the launch of the Walmart Healthcare Research Institute, as the retail giant focuses on high-margin businesses in healthcare.
Walmart said the venture is meant to improve diversity in clinical trials, focusing on interventions and medications that can make an impact in underrepresented communities. That includes older adults, rural residents, women and minority populations, the company said in a release.
It could also become a valuable stream of revenue for Walmart from drug companies looking for participants for potential trials and studies.
The NIH Directors’ Blog tells us about two NIH-supported chemists, Carolyn R. Bertozzi and K. Barry Sharpless, who won the 2022 Nobel Prize in Chemistry for their work in click chemistry.
This form of chemistry has made it possible for researchers to snap together, like LEGO pieces, molecular building blocks to form hybrid biomolecules, often with easy-to-track imaging agents attached. Not only has click chemistry expanded our ability to explore the molecular underpinnings of a wide range of biological processes, but it has provided us with new tools for developing drugs, diagnostics, and a wide array of “smart” materials.
Merck on Wednesday agreed to extend an ongoing collaboration with Moderna to develop a personalized vaccine for the treatment of patients with skin cancer.
Moderna is getting $250 million from Merck to secure opt-in rights to the cancer vaccine candidate, called mRNA-4157. The two companies are jointly conducting a mid-stage clinical trial that combines the customized, mRNA-based vaccine with Merck’s checkpoint inhibitor Keytruda.
Results from this randomized study will be announced before the end of the year, but the timing of Wednesday’s deal suggests Merck and Moderna have seen enough encouraging data to advance mRNA-4157 into larger studies.
From the Rx coverage front, the HHS Agency for Healthcare Research and Quality updated its consumer tool “How To Create a My Medicines List,” previously known as “My Pills List.”
From the healthcare quality front, NCQA released a slide deck and recording of last week’s Future of HEDIS webinar focused on health equity.
From the maternity care front, Health Day reports on a March of Dimes report on maternity care deserts and related matters. Here’s the federal government’s maternity care map:
Maternity care deserts [red]: low access [orange]; moderate access [yellow]; full access [light purple] Source: U.S. Health Resources and Services Administration (HRSA), Area Health Resources Files, 2021
From the Affordable Care Act front, the International Foundation of Employee Benefit Plans explains
The Internal Revenue Service (IRS) issued final regulations on affordability of employer coverage for family members of employees.
The final regulations under section 36B of the Internal Revenue Code (Code):
* Amend the regulations regarding eligibility for the premium tax credit (PTC) to provide that affordability of employer-sponsored minimum essential coverage (employer coverage) for family members of an employee is determined based on the employee’s share of the cost of covering the employee and those family members, not the cost of covering only the employee;
* Add a minimum value rule for family members of employees based on the benefits provided to the family members; and
* Affect taxpayers who enroll, or enroll a family member, in individual health insurance coverage through a Health Insurance Exchange (Exchange) and who may be allowed a PTC for the coverage.
The final regulations are effective 60 days after publication in the Federal Register.
IRS issued Notice 2022-41 in conjunction with regulations under section 36B.
The notice expands the application of the permitted change-in-status rules for health coverage under a section 125 cafeteria plan (cafeteria plan). In particular, the notice addresses the situation in which, during a period of coverage (typically a plan year), a cafeteria plan participant may wish to revoke the employee’s election under the cafeteria plan for other than-self-only (family) coverage under a group health plan (other than a flexible spending arrangement (FSA)) in order to allow one or more family members to enroll in a Qualified Health Plan (QHP) through a Health Insurance Exchange (Exchange) in the individual market.
Under the notice, the employee will be able to elect out of family coverage and into self-only coverage (or family coverage including one or more already-covered related individuals) under that health plan prospectively during a period of coverage, provided specific conditions are satisfied.
The Department of the Treasury and IRS intend to modify the Income Tax Regulations under section 125 of the Code consistent with the provisions of the notice.
Taxpayers may rely on the guidance in the notice for plan amendments allowing elections effective on or after January 1, 2023.
These rules are intended to fix the so-called “family glitch” in the ACA. Responsibility for implementing this rule in the FEHB Program falls on the employer, here OPM. More to follow on Wednesday because the FEHBlog needs to understand this change better.
Speaking of ACA changes, the U.S. Preventive Task Force gave a B grade to a modified description of its recommendation for primary care physicians to screen asymptomatic adolescents aged 12 to 18 for major depressive disorder and suicide risk. The USPSTF also expanded its new B grade anxiety screening recommendation for adults to asymptomatic adolescents and children aged 8 to 18.
Access to and availability of mental health providers must be expanded as well. Healthcare IT News reports on “how telehealth can help curb the mental health staffing shortage. A physician and virtual care expert discusses how demand for behavioral health services is increasing and what telemedicine can do to meet these needs. He shows how the tech can help serve vulnerable populations.”
In the U.S healthcare business news, Healthcare Dive informs us
Walgreens is buying the remaining 45% stake in post-acute and home care services provider CareCentrix for roughly $392 million, the pharmacy giant said Tuesday.
Walgreens acquired a 55% majority stake in CareCentrix, which coordinates home care for health plans, patients and medical providers, for $330 million in a deal that closed earlier this year.
The Illinois-based retailer has said the buy will expand its reach in the health sector, especially in the fast-growing areas of primary.
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